Method and apparatus for triage and subsequent escalation based on biosignals or biometrics

ABSTRACT

Provided is an electronic device to monitor a user&#39;s biological measurements in two stages, where the first stage determines whether to make measurements and/or appraisals in the second stage.

RELATED APPLICATION(S)

This application is a continuation application of U.S. application Ser.No. 15/145,356, filed on May 3, 2016, which claims the benefit of theU.S. Provisional Application 62/313,053, filed on March 24, 2016, nowexpired, the disclosure of which is incorporated herein in its entiretyby reference.

BACKGROUND

The present disclosure relates to measuring a user's body signals, andmore particularly, to a method and apparatus for using triage andsubsequent escalation based on biosignals or biometrics.

Wearable sensor devices that provide biosignals typically have inherenttrade-offs. For example, a wearable device that provides more backgroundmonitoring typically requires less user involvement. In another example,a wearable device that provides less sensitive signal quality typicallyhas longer battery life. A wearable device that provides less sensitivesignal quality may also have better user comfort/acceptance. Typically,longer battery life can be provided for a wearable device by providingless information content. Therefore, a wearable sensor device typicallyprovides background monitoring with maximum user comfort/acceptance,long battery life, and less sensitive sensor signals.

Some wearable sensors can continuously acquire information from a userwithout the user's participation, thus allowing unobtrusive, nearcontinuous monitoring for abnormal conditions or providing a trend forhealth, fitness, wellness, and/or disease states. Although such wearablesensors (e.g., a photoplethysmogram (PPG), a galvanic skin response(GSR) sensor, a bioimpedence sensor, a skin temperature sensor, and anoximeter) provide useful information, these sensors are typicallysensitive to noise contamination due to motion or variable skin contact.These sensors may also not be as clinically researched/accepted and aretherefore less relevant for diagnostic evaluation.

Other sensors and/or diagnostic procedures, though more clinicallyaccepted and relevant, may be less convenient to use for the user.Therefore, data from such sensors are not able to be collected by nearcontinuous monitoring (e.g., electrocardiogram (ECG), impedancecardiograph (ICG), core body temperature, and nystagmus test).

SUMMARY

Provided are method and apparatus for continuous triage and subsequentescalation based on biosignals or biometrics. According to an exemplaryembodiment, a method may include acquiring first signals in a first modefrom a user via a first sensor of a user-wearable device, and processingthe first signals to determine whether to enter a second mode to providefurther information to the user. Another exemplary embodiment mayinclude a first sensor of a user-wearable device configured to acquirefirst signals in a first mode from a user, and a diagnostic processorconfigured to process the first signals to determine whether to enter asecond mode to provide further information to the user. Anotherexemplary embodiment may include a non-transitory machine-readablemedium storing machine executable instructions that when executed causesa computing system to control operations comprising acquiring firstsignals in a first mode from a user by a first sensor of a user-wearabledevice, and processing the first signals by a diagnostic processor todetermine whether to enter a second mode to provide further informationto the user.

Additional aspects will be set forth in the description that followsand/or learned by practice of the presented exemplary embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

These and/or other aspects will become apparent and more readilyappreciated from the following description of the exemplary embodiments,taken in conjunction with the accompanying drawings.

FIG. 1 is a diagram illustrating an electronic device in accordance withan embodiment of the present disclosure.

FIG. 2 is a high-level block diagram of an electronic device inaccordance with an embodiment of the present disclosure.

FIG. 3 is an illustration of an electronic device in a communicationnetwork in accordance with an embodiment of the present disclosure.

FIG. 4 is an exemplary notification by the electronic device to the userfor acquiring signals in a second mode.

FIG. 5 is an exemplary flowchart for determining whether to enter asecond mode.

DETAILED DESCRIPTION

Advantages and features of one or more embodiments of the presentdisclosure may be understood more readily by reference to the followingdetailed description of the embodiments and the accompanying drawings.

In this regard, the present embodiments should not be construed as beinglimited to the descriptions set forth herein. Rather, these embodimentsare provided as examples so that this disclosure will be thorough andcomplete and will fully convey the concept of the present embodiments toone of ordinary skill in the art. The appended claims illustrate some ofthe embodiments of the present disclosure.

Like reference numerals refer to like elements throughout thespecification. All terms including descriptive or technical terms usedherein should be construed as having meanings that are obvious to one ofordinary skill in the art. When a term has an ambiguous meaning due toevolving of language, precedent cases, or the appearance of newtechnologies, the meaning of a term used in this disclosure should firstbe clarified by its usage and/or definition in this disclosure. Iffurther clarification is needed, the term should then be clarified asone of ordinary skill in the art would have understood the term incontext of the disclosure at the time of the disclosure.

When a part “includes” or “comprises” an element, unless there is aparticular description contrary thereto, the part can further includeother elements. The term “unit” in the embodiments of the presentdisclosure means a software component or a hardware component thatperforms a specific function. The hardware component may include, forexample, a field-programmable gate array (FPGA) or anapplication-specific integrated circuit (ASIC).

Software component may refer to executable code and/or data used by theexecutable code in an addressable storage medium. Thus, softwarecomponents may be, for example, object-oriented software components,class components, and task components, and may include processes,functions, attributes, procedures, subroutines, segments of programcode, drivers, firmware, micro codes, circuits, data, a database, datastructures, tables, arrays, or variables.

A function provided by a “unit” may be divided into additionalcomponents and “units.”

Reference will now be made in detail to embodiments, examples of whichare illustrated in the accompanying drawings. In this regard, thepresent embodiments may have different forms and should not be construedas being limited to the descriptions set forth herein.

In the following description, well-known functions or constructions arenot described in detail so as not to obscure the embodiments withunnecessary detail.

FIG. 1 is a diagram illustrating an electronic device in accordance withan embodiment of the present disclosure. Referring to FIG. 1, anelectronic device, which includes a user-wearable device 100, has adisplay 102, processors 110 and 112, a sensor module 120, a battery 130,a band 140, and a clasp 142. The sensor module 120 may include sensors122 and 124.

Although the user-wearable device 100 may be worn on a wrist, variousembodiments of the disclosure need not be so limited. The user-wearabledevice 100 may also be designed to be worn on other parts of the body,such as, for example, on an arm (around the forearm, the elbow, or theupper arm), on a leg, around the chest, around the head like a headband,around the throat like a “choker,” and on an ear. The user-wearabledevice 100 may be able to communicate with other electronic devices suchas, for example, a smart phone or a laptop. This will be described inmore detail with respect to FIG. 3.

The display 102 may output monitored physiological signals from theuser's body for viewing by the user and/or others. The signals beingmonitored may be referred to as biosignals or biometric data. Themonitored signals may be, for example, pulse rate, pulse morphology(shape), and/or pulse spacing (inter-beat intervals). The display 102may also output instructions to the user or others in the use of theuser-wearable device 100 or use of other measurement devices, as well asstatus and diagnostic results.

The processor 110 may process the monitored signals to determine whethera more detailed monitoring and/or a different type of monitoring may beneeded. The sensor module 120 may include, for example, the sensors 122and 124 that touch the user's wrist when the user-wearable device 100 isworn by a user. The processor 112 may control the sensors 122 and 124,and may also process the signals monitored by the sensors 122 and 124.For example, the processor 112 may filter noise from the signalsmonitored by the sensors 122 and 124. Various embodiments of thedisclosure may have the processor 110 also perform the functions of theprocessor 112. Various embodiments of the disclosure may also havedifferent number of sensors.

The sensor 122 may be, for example, a PPG sensor that is used tocontinuously or near continuously monitor pulse related information. Thesensor 124 may be a more sensitive type of a PPG sensor that is usedwhen the processor 110 determines that further signal monitoring isneeded using a more sensitive sensor, a sensor that is more relevant tothe specific signals being monitored, or a sensor that may have greateruse acceptance by, for example, medical professionals for monitoringcertain biosignals or biometric data. That is, a sensor with greatersensitivity, specificity, and/or acceptability may be used. The sensor124 may be, for example, an ECG sensor.

The battery 130 may be configured to provide power for the user-wearabledevice 100. The battery 130 may be charged using a wired charging systemor a wireless charging system. The band 140 may be wrapped around awrist and the user-wearable device 100 may be held on the wrist by usingthe clasp 142.

The user-wearable device 100 may provide continuous monitoring, orperiodic monitoring. The specific type of monitoring may be designand/or implementation dependent, and may also include an option thatallows the user to select the type of monitoring. Periodic monitoringmay alternate monitoring period and a non-monitoring period. Periodicmonitoring may be to allow for longer battery life.

FIG. 2 is a high-level block diagram of an electronic device inaccordance with an embodiment of the present disclosure. Referring toFIG. 2, there is shown the display 102, the processor 110, the sensormodule 120, and the battery 130. Output to the display 102 may becontrolled by the processor 110. The display 102 may also include inputdevices (not shown) such as, for example, buttons, dials, touchsensitive screen, and microphone.

The processor 110 may include a CPU 200, memory 210, an input/output(IO) interface 220, a communication interface 230, and a powermanagement unit (PMU) 240. While the processor 110 is described ascomprising these various devices, other embodiments may use otherarchitectures where the different functionalities are groupeddifferently. For example, the grouping may be in different integratedcircuit chips. Or the grouping may be combining different devices suchas the IO interface 220 and the communication interface 230 together.

The CPU 200 may control operation of the sensor module 120 as well asreceive monitored signals from the sensor module 120. The CPU 200 maycontrol the user-wearable device 100, including processing the monitoredsignals from the sensor module 120, displaying the processed signals onthe display 102, receiving input from the display 102, interfacing withvarious devices via the IO interface 220 or the communication interface230 by executing instructions in the memory 210. The IO interface 220may be used by the CPU 200 to interface with the display 102.

The processor 112 may operate using different architectures in differentembodiments. For example, the processor 112 may use the memory 210 tostore instructions to execute, or the processor 112 may have its ownmemory (not shown) for its instructions. Although some embodiments haveseparate processors 110 and 112, the various embodiments need not belimited so. There may be one processor 110 that controls thefunctionality of the user-wearable device 100, or there may be multipleprocessors for the user-wearable device 100.

The memory 210 may include non-volatile memory 216 and volatile memory218. The operating system and applications may be stored in thenon-volatile memory 216. Various embodiments of the disclosure may usedifferent memory architectures that are design and or implementationdependent.

The communication interface 230 may allow the user-wearable device 100to communicate with other devices via, for example, a wired protocolsuch as USB or a wireless protocol such as Bluetooth, Near FieldCommunication (NFC), and WiFi. The PMU 240 may control receiving powerfrom an outside source, charging the battery 130, as well as allocationof power to the different parts of the user-wearable device 100.

FIG. 3 is an illustration of an electronic device in a communicationnetwork in accordance with an embodiment of the present disclosure.Referring to FIG. 3, there is shown the user-wearable device 100 and asmartphone 300. The user-wearable device 100 may communicate with thesmartphone 300 using the communication interface 230. The communicationmay be via communication signals 302 between the user-wearable device100 and the smartphone 300. The communication signals 302 may be via awired communication protocol or a wireless communication protocol.Although not shown, the communication signals 302 may be sent via one ormore communication units between the user-wearable device 100 and thesmartphone 300. For example, the user-wearable device 100 and thesmartphone 300 may belong to the same network or different networks.

One of the applications 214 of the user-wearable device 100 may allowthe smartphone 300 to control at least some operation of theuser-wearable device 100 via the communication signals 302. For example,user-wearable device 100 may output to the display 102 a result of theprocessing by the processor 110, and/or the same result may betransmitted to the smartphone 300. The user may then select an optioneither on the user-wearable device 100 or on the smartphone 300.

The options may be, for example, to use the sensor 124 on theuser-wearable device 100 that is more sensitive than the sensor 122 thatwas used up to now, to use another monitoring device that may need to beput on by the user, or to repeat monitoring with the sensor 122.

Since the smartphone 300 has a larger display, it may be easier for theuser to select an option on the smartphone 300 rather than on theuser-wearable device 100. However, it should be noted that thesmartphone 300 may not generally be necessary for operation of theuser-wearable device 100.

FIG. 4 is an exemplary notification by the electronic device to the userfor acquiring signals in the second mode of monitoring. Referring toFIG. 4, status may be shown on the display 102 when no user interventionis required. The status may indicate, for example, that no anomalieshave been detected in the first mode of monitoring where theuser-wearable device 100 monitors the user continuously or nearcontinuously with no need for intervening action by the user. The statusmay be, for example, that the sensor 122, which may measure the pulse ofthe user in some embodiments, does not detect the pulse to be out of anormal range for a typical person having the user's characteristics. Thecharacteristics may include, for example, sex, height, and weight. Thesecharacteristics may be entered directly into the user-wearable device100 or via, for example, the smartphone 300.

When the processor 110, which may be referred to as a diagnosticprocessor, determines that the monitored signals from the sensor 122indicates that further measurements need to be taken, instructions tothe user may be displayed on the display 102. The instructions mayindicate, for example, that the user needs to adjust the user-wearabledevice 100 to be tighter on the wrist so that the sensor 124, which maybe a more sensitive sensor than the sensor 122, may acquire moreaccurate reading. Or, the instructions may indicate that the user shouldrest for a period of time before continuing with further monitoring inthe second mode. Or, the instructions may indicate that the user needsto put on another more specialized monitoring device.

Various embodiments of the disclosure may include different instructionsfor different types of monitoring, including instructing the user toconsult a medical professional. Accordingly, the user-wearable device100 may have different levels of instructions and monitoring dependingon the needs of the user and/or the medical professional.

According to some embodiments, the sensor 122 may monitorbackground-acquired signal data in the first mode to determine whetherto enter triage states in the second mode. Entering the triage statesmay require user involvement (e.g., a change in fit or behavior), totrigger the use of a second sensor device such as the sensor 124 thatmay have higher power consumption than the first sensor device such asthe sensor 122. The higher power may be needed for improved signalquality, to change a type of signal acquisition and/or processing theacquired signals, and/or to perform an advanced method of physiologicalmonitoring of the user.

FIG. 5 is an exemplary flowchart for determining whether to enter asecond mode. Referring to FIG. 5, there is shown operations 500 to 512.At 500, the user-wearable device 100 enters the first mode to monitorsome of the user's biosignals or biometric data via the sensor 122. Thesensor 122 may acquire sensor signals that may be of low quality due tonon-ideal contact between the sensor 122 and the user, and due to thesensor 122 being less sensitive than, for example, the sensor 124 or anexternal sensor (not shown).

If the sensor 122 is a PPG sensor, the acquired biosignals will berelated to the user's pulse. The user-wearable device 100 may start theacquisition upon being turned on by operating in the background withoutuser input during the acquisition. For some types of biosignalacquisition, the user may need to enter some information prior to theacquisition. The information may be, for example, sex, height, andweight that may be relevant to processing the biosignals.

At 502, the sensor 122 acquires biosignals. At 504, the processors 110and/or 112 determine whether to proceed to a second mode based on theacquired biosignals. The processors 110 and/or 112 may determine thatthe acquired biosignals from the sensor 122 may not be normal, forexample, based on a predetermined threshold, or because the acquiredbiosignals are different from prior biosignals from the user. The priorbiosignals may have been acquired in previous sessions or may have beendownloaded to the user-wearable device 100 and stored in the memory 210.

If the processors 110 and/or 112 determine not to proceed to the secondmode, the sensor 122 continues to acquire biosignals from the user at502. If the processors 110 and/or 112 determine to enter the secondmode, the user-wearable device 100 displays instructions on the display102 at 506. The instructions may be, for example, to further acquirebiosignals using the more sensitive sensor 124 or an external sensor(not shown). Or, the instructions may be for some processes that do notrequire additional sensor measurements. For example, the instruction maybe to visit a doctor for more detailed tests.

The sensor 124 may be a traditional sensor and/or provide more relevantand/or sensitive sensor signals than the sensor 122. Usage of the sensor124 may require the user to perform a specific procedure that providesgreater diagnostic and/or sensing capabilities. For example, the usermay be instructed to tighten the band 140 to allow better contactbetween the sensor 124 and the user's skin. Or the user may be told topose or hold still for a period of time, or to hold the sensor module120 or an external sensor on the user's body in one or more specificpositions/orientations to maximize signal quality from a body part.

Having the user pose in a specific position may allow observation ofspecific measurable quantities that are not otherwise observable. Forexample, the user might be asked to raise their arm to see how thehydrostatic pressure changes impact the blood flow in their arm. Withouthaving the user move their arm, this information may not be able to beacquired.

In another embodiment, the sensor 122 may acquire skin temperature, andthe user-wearable device 100 may determine that the temperature ishigher than a predetermined threshold temperature for the user. Thedisplay 102 may output an instruction for the user to performtemperature measurement using an oral or temporal thermometer.

In another embodiment, the biosignals acquired by the sensor 122 mayindicate spectral characteristics of significantly increased bloodalcohol levels. Accordingly, the user-wearable device 100 may provideinstructions to the user on the display 102 to perform a horizontal gazenystagmus test to determine a sobriety state of the user and his/hercapability to operate a vehicle.

In another embodiment, the sensor 122 may acquire GSR signals from awrist-worn device, and the user-wearable device 100 may determine thatthe GSR signals indicates a level of sympathetic nervous systemactivation that does not satisfy a predetermined threshold for the user.This may trigger the user-wearable device 100 to provide one or morequestions to the user to determine his/her cognitive state in an attemptto recognize an altered mental state.

At 508, if biosignals are to be acquired using a more sensitive sensor,the user-wearable device 100 may acquire biosignals at 510 with thesensor 124 that may be more sensitive than the sensor 122. Thebiosignals may be processed to determine a diagnosis or next step ofaction. If biosignals are not to be acquired by the second sensor of theuser-wearable device 100, then, in an embodiment of the disclosure, theuser-wearable device 100 may enter the first mode at 500. This mayoccur, for example, if instructions were given at 506 to visit a doctoror if an external sensor is to be used for further monitoring ofbiosignals. Additionally, while an embodiment may enter the first modeat 500 if further monitoring is not needed using the second sensor,various embodiments of the disclosure need not be so limited. Forexample, the user-wearable device 100 may enter a stand-by state untilthe user enters an input to start the biosignal acquisition at 500. Thespecific action to be taken will depend on design and/or implementationdecisions.

At 512, after processing signals acquired by the sensor 124 the user maybe given a result of the biosignal monitoring. The user may be told toperform, for example, an electro-cardiogram (ECG) recording to diagnosefor heart rhythm anomalies/abnormalities. Even if the sensor 124 is anECG sensor, in some instances there may be instructions to have anotherECG recording performed by an external device. The monitoring by anexternal device may need to be done at a doctor's office, or possibly bythe user if the user has an external device able to make ECG recordings.

Various embodiments have described the user-wearable device 100 to bedirected to monitoring some of a user's biosignals or biometric data;however other embodiments may monitor different biosignals than thosementioned in this disclosure.

Additionally, while some actions may have been taken due to instructionsat 506 (e.g., skin temperature, blood alcohol level, GSR, and signals),various embodiments may continue on to take more accurate measurementsat 508 and 510.

Various embodiments of the disclosure may be written as computerprograms and may be implemented in general-use digital computers thatexecute the programs using a non-transitory computer-readable recordingmedium.

Non-transitory computer-readable recording medium may include, forexample, magnetic storage media (e.g., ROM, floppy disks, and harddisks), and optical recording media (e.g., CD-ROMs, or DVDs).

While various embodiments of the disclosure have been described withreference to the figures, it will be understood by those of ordinaryskill in the art that various changes in form and details may be madetherein without departing from the spirit and scope of the disclosure asdefined by the following claims. Accordingly, the above embodiments andall aspects thereof are examples only and are not limiting.

1-20. (canceled)
 21. A user-wearable monitoring device, comprising: aphotoplethysmogram (PPG) sensor configured to monitor heart relatedinformation for a user as a first level of monitoring for arrhythmia; adisplay configured to output visual information to the user; and adiagnostic processor configured to: process PPG signals from the PPGsensor to determine whether to enter a second level of monitoring forarrhythmia in the user; and upon determining to enter the second levelof monitoring: determine whether to acquire electrocardiogram (ECG)signals of the user with an ECG sensor that is a part of theuser-wearable monitoring device; upon determining to acquire the ECGsignals with the ECG sensor: acquire the ECG signals of the user;process the acquired ECG signals; and provide to the user, on thedisplay, at least one result of the processed ECG signals.
 22. Theuser-wearable monitoring device of claim 21, wherein the diagnosticprocessor is configured to, upon determining to enter the second levelof monitoring, provide on the display at least one notification to theuser.
 23. The user-wearable monitoring device of claim 21, wherein thediagnostic processor is configured to, upon determining to not acquirethe ECG signals, perform one of: enter the first level of monitoring orenter a standby state.
 24. The user-wearable monitoring device of claim21, wherein the diagnostic processor is configured to, upon determiningto not acquire the ECG signals, enter a standby mode until the userindicates via an input interface to enter the first level of monitoringto continue to acquire a new set of the PPG signals.
 25. Theuser-wearable monitoring device of claim 21, wherein the diagnosticprocessor is configured to, upon determining to enter the second levelof monitoring, provide at least one question to the user to appraise acognitive state of the user based on the user answering the at least onequestion.
 26. The user-wearable monitoring device of claim 21, whereinthe user-wearable monitoring device is in an idle state until the userprovides an input via an input interface to enter the first level ofmonitoring for arrhythmia in the user.
 27. The user-wearable monitoringdevice of claim 21, wherein, upon determining to enter the second levelof monitoring, the diagnostic processor is configured to provide atleast one notification via the display to the user.
 28. Theuser-wearable monitoring device of claim 27, wherein the diagnosticprocessor is configured to determine to acquire the ECG signals based ondetermining that the user has responded to at least one of the at leastone notification.
 29. The user-wearable monitoring device of claim 21,wherein upon determining to enter the second level of monitoring thediagnostic processor is configured to provide a notification asking theuser to use an external sensor other than the user-wearable monitoringdevice.
 30. A method comprising: monitoring heart related informationfor a user as a first level of monitoring for arrhythmia using aphotoplethysmogram (PPG) sensor that is a part of a user-wearablemonitoring device; outputting visual information to the user on adisplay; and processing PPG signals output by the PPG sensor todetermine whether to enter a second level of monitoring for arrhythmiain the user, wherein: upon determining to enter the second level ofmonitoring: determining whether to acquire electrocardiogram (ECG)signals of the user with an ECG sensor that is a part of theuser-wearable monitoring device; upon determining to acquire the ECGsignals with the ECG sensor: acquiring the ECG signals of the user;processing the acquired ECG signals; and providing to the user at leastone result of the processed ECG signals on the display.
 31. The methodof claim 30, wherein, upon determining to not acquire the ECG signals,entering a standby mode until the user indicates via an input to enterthe first level of monitoring to continue to acquire a new set of thePPG signals.
 32. The method of claim 30, upon determining to not enterthe second level of monitoring, continuing to acquire the PPG signals.33. The method of claim 30, wherein determining whether to acquire theECG signals does not depend on an input from the user.
 34. The method ofclaim 30, wherein the second level of monitoring comprises one or moreof: acquiring the ECG signals with improved signal quality compared to asignal quality of the PPG signals, changing a type of signal acquisitionfor acquiring the ECG signals, changing processing of the PPG signalsand/or the acquired ECG signals, and performing an advanced method ofphysiological monitoring of the user.
 35. The method of claim 30,comprising, upon determining to enter the second level of monitoring,outputting on the display at least one question to the user to appraisea cognitive state of the user based on the user answering the at leastone question.
 36. The method of claim 30, comprising, upon determiningto enter the second level of monitoring, outputting on the display atleast one notification to the user.
 37. The method of claim 36, whereindetermining to acquire the ECG signals is based on determining that theuser has responded to at least one of the at least one notification. 38.The method of claim 30, comprising, upon determining to enter the secondlevel of monitoring, providing a notification asking the user to use anexternal sensor other than the user-wearable monitoring device.
 39. Asystem comprising: a first sensor of a user-wearable device configuredto acquire first signals in a first mode from a user; a displayconfigured to output visual information to the user; and a diagnosticprocessor configured to: process the first signals to determine whetherto enter a second mode; and upon determining to enter the second mode:provide, on the display, at least one instruction to the userappropriate for the second mode; determine whether to acquire secondsignals with a second sensor; upon determining to acquire the secondsignals: acquire the second signals; process the acquired secondsignals; and provide, on the display, at least one notification to theuser based on the processed second signals.
 40. The system of claim 39,wherein when the user-wearable device is in a standby mode, wait untilthe user indicates via an input to enter the first mode to continue toacquire a new set of the first signals.